臺灣博碩士論文加值系統

高齡化的人口結構，使得慢性疾病成為全球的健康大敵，在醫療科技產業與國際同步發展的臺灣，要如何有效培養並結合專業的人力，共同來提昇國家整體的競爭力，使新藥早日在臺上市，嘉惠民眾，實乃當前之重要課題。
本研究以醫療科技最重要的藥物臨床研究階段為背景，探討臨床試驗中的關鍵性角色-研究護士，研究目的為瞭解研究護士從事臨床試驗活動或責任的頻率，對自我專業角色的看法以及臺灣研究護士之專業角色資格、組織特性及基本資料對臨床試驗活動之影響。研究採橫斷式研究法，共收集全臺十九家醫學中心從事臨床試驗之123 位現職的研究護士樣本，以統計軟體SPSS10.0進行描述性及推論性統計分析，研究結果顯示，臺灣研究護士實際從事臨床試驗活動的頻率，以受試者的招募、知情同意的過程、試驗產品、執行與評估、資料處理所佔比率最高；是否為專業組織會員、護理年資的深淺、組織中是否有工作相關的標準作業程序及是否有專業發展的升遷途徑或機會、組織中的直屬主管是否為醫師外的其他人員、研究護士的工作薪資等，對所從事臨床試驗活動的頻率和重要性皆有顯著的差異性，而參加教育訓練的次數愈頻繁，所從事的臨床試驗活動頻率愈為顯著；研究護士對本身臨床試驗活動頻率的執行和重要性的認知愈強，則專業護理角色的看法愈為顯著；研究護士參加教育訓練次數的多寡，與其護理角色的工作表現和專業護理角色的看法，有顯著的高度相關，是否曾參與第二階段或第三階段試驗、職位的不同、工作的地理位置不同，對試驗活動從事的頻率和重要性認知，都有極顯著的相關性。期盼經由本研究的歸納、分析及整理，能提供給研究產業相關的產官學界，對臨床研究的專業人力養成，有不同層面的觀感及參考評量依據。

As the result of aging population, chronic diseases become serious worldwide health problems. Following the international trend, Taiwan develops her pharmaceutical industry. For the benefit of the public, it is important to learn how to effectively train and integrate the clinical investigators to enhance the country’s competence and to accelerate the launch of new drugs in Taiwan. The phases of clinical trials are the most important parts to develop new pharmaceuticals. Under the phases, the study nurses, the key role of clinical trials, are investigated. The objectives of this study include as below: first, the frequency of study nurses involved in the activities or taking responsibilities of clinical trials; second, the view of study nurses on their professional role; and third, the influence of their professional qualification, organizational and individual characteristics on clinical trial activities. This study was conducted by the cross-sectional method and SPSS 10.0 software. One hundred and twenty three study nurses were enrolled from the nineteen medical centers in Taiwan. The result shows that the most routine clinical trial activities of study nurses in Taiwan are subject enrollment, informed consent process, investigational product management, implementation, evaluation and data management. There are some significant factors about the frequency and importance of clinical trial activities, such as the professional organizational membership, the nursing experience, the availability of job-related standard operation procedures, the policy and opportunity of professional promotion, and the line manager who is a physician or not , the salary of study nurse, and so on.
Study nurses who receive trainings more often would participate in clinical trial activities more frequently. Study nurses’ opinion on their professional roles would be more significant while they recognize the implementation and importance of clinical trial activities more strongly. There are correlated between the number of trainings of study nurses, their performance as nurses, and their perspectives on the professional roles of nurses. The experience of conducting phase II or phase III clinical trials, different job positions, different job locations may be the predictors to identify the frequency and importance of conducting clinical study activities. By the study result, it is expected to provide some new ideas of assessment on the trainings of clinical investigators for the clinical trial industry.

第一章 緒論-1
第一節 研究緣起與目的-1
第二節 名詞解釋與定義-5
第二章 文獻探討-6
第一節 國際規範與新藥研發-6
第二節 臺灣臨床試驗與生物科技產業概況-10
第三節 慢性疾病與臨床試驗-14
第四節 臨床研究護士概述-16
第五節 研究護士的工作規劃與發展-28
第三章 研究方法-35
第一節 研究架構與流程-35
第二節 研究對象與範圍-40
第三節 問卷設計-41
第四節 調查計畫-43
第四章 研究結果-48
第一節 研究護士個人基本資料、組織特性與專業護理角色資格-49
第二節 研究護士之專業護理角色活動、責任及看法-55
第三節 臨床研究護理活動與不同變項間差異性分析-63
第四節 研究護士臨床試驗護理活動之相關分析-86
第五節 臨床試驗護理活動與各變項間之複迴歸分析-90
第五章 討論-107
第一節 個人基本資料、組織特性與專業護理角色資格之探討-107
第二節 研究護士臨床試驗護理活動或責任及角色看法之探討-110
第三節 臨床研究護理活動與不同變項之差異性及相關性-113
第四節 基本資料、特性和資格對活動頻率和重要性之預測-117
第五節 研究限制-121
第六章 結論與建議-122
第一節 結論-122
第二節 建議-125
參考文獻-127
附錄
附錄一 臨床試驗護理問卷英文原始版-132
附錄二 臨床試驗護理問卷中文版-133
附錄三 問卷之操作型定義-149
附錄四 人體試驗研究計畫許可書-162
附錄五 研究單位同意書-163

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